Senior Engineer II, Device Development (Drug Delivery Devices)

Location: Hybrid role based at hirify.global headquarters in Cambridge, Massachusetts, United States

Base compensation: $117,000–$157,000 per year

Company

hirify.global is a mid-sized biotechnology company developing life-changing medicines and combination products.

What you will do

• Design, develop, and manage the lifecycle of patient-centric drug delivery devices and combination products.
• Develop Design History File and Device Master Record content, including requirements, design outputs, traceability, specifications, and test methods.
• Perform risk assessments, root cause investigations, impact assessments, and technical evaluations for design, process, and supplier issues.
• Plan and oversee verification and validation activities at contract laboratories, including experimental plans, data analysis, reports, and troubleshooting.
• Lead cross-functional workstreams with Device Development, Human Factors, Packaging, Manufacturing, Quality, Regulatory, Clinical, Commercial, suppliers, and external partners.
• Support innovation, product planning, regulatory filings, and responses for drug delivery systems and combination products.

Requirements

• Bachelor’s degree in biomedical, electrical, mechanical, or related engineering and at least 6 years of device or combination product development experience.
• At least 3 years of experience with drug delivery and combination products, such as autoinjectors, pre-filled syringes, wearable injectors, pen injectors, or drug reconstitution devices.
• Experience taking medical devices or combination products from concept through commercialization and supporting new product introduction.
• Knowledge of ISO 13485, ISO 14971, 21 CFR Part 4, 510(k), PMA, MDD, MDR, and applicable US and EU regulatory expectations.
• Experience with engineering analysis, including first-principles modeling and FEA, prototyping, development, and testing of molded, extruded, or assembled devices.
• Ability to work in a hybrid arrangement based at the Cambridge, MA headquarters.

Nice to have

• Advanced degree in a relevant engineering discipline.
• Experience with JAMA DOORS, Polarion, Codebeamer, or similar requirements and risk-management tools.
• Experience launching drug-device combination products or developing electromechanical, handheld, or connected drug delivery technologies.
• Knowledge of Design of Experiments, Design for Six Sigma, and Design for Manufacturing.
• Fluency in artificial intelligence and experience integrating AI-enabled tools into engineering workflows.

Culture & Benefits

• Medical, dental, vision, life, short-term disability, and long-term disability insurance.
• Paid vacation, company holidays, year-end shutdown time, sick time, and parental leave.
• 401(k) plan with company matching, equity incentives, employee stock purchase plan, and cash bonus opportunities.
• Fitness and wellness programs, including fitness reimbursement.
• Tuition reimbursement of up to $10,000 per calendar year.
• Inclusive environment with employee resource groups and opportunities for learning and professional growth.